Saleem A. Akhtar
Consumer Safety Officer / Drug Investigator
FDA ORA New Jersey District (Parsippany, NJ)
High-volume international drug investigator with ~95 inspections across 15 countries — specialising in cleaning validation, cross-contamination, and laboratory data integrity, with four inspections escalating to warning letters and one triggering an import alert.
Inspection Approach
How Saleem Inspects
Akhtar follows a contamination-tracing methodology: he starts with cleaning validation records, evaluates whether the worst-case API and hardest-to-clean surfaces were correctly identified, and then checks whether actual finished product batches show evidence of cross-contamination. At Zydus Lifesciences in 2024, he found the Cleaning Validation Master Plan had misidentified the hardest-to-clean API — then traced the gap to actual cross-contaminated finished drug product on the affected line. At Cadila Healthcare in 2019, a similar cleaning-to-contamination chain led to a warning letter.
His second signature is complaint investigation depth. At Cipla Pithampur in 2023, he documented that over 3,000 complaints for Albuterol Sulfate MDIs had accumulated between April 2020 and December 2022 without adequate investigation or extension to other batches — a finding that became the centrepiece of a warning letter. He consistently checks whether complaint investigations are extended to potentially affected lots, whether trending is performed, and whether root cause analysis is genuine or performative.
In laboratory settings, Akhtar probes data integrity at the electronic record level. At Dr. Reddy's Bachupally in 2023, he found that CD Spectropolarimeter data for a sameness study had been omitted from the report submitted to FDA, original electronic data was not attributable to specific batches, and equipment use logbook page 99 had gone missing with the original notebook destroyed. He consistently checks whether raw electronic data matches summary reports — and whether metadata (timestamps, user IDs, instrument parameters) is complete and traceable.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Sun Pharmaceutical Industries Ltd.
- Metallic particle contamination found in finished drug products
- 10 observations issued across CGMP violations
- Inspection led to Warning Letter (636199, Oct 2023) and Import Alert 66-40 (Dec 2022)
- Co-investigator: Jose M. Cayuela
Cipla Limited (Indore SEZ)
- Over 3,000 complaints for Albuterol Sulfate MDIs (Apr 2020–Dec 2022) not adequately investigated
- Failure to extend complaint investigations to other potentially affected batches
- Inspection led to Warning Letter (660904, Nov 2023)
- Co-investigator: Jose E. Melendez
Cadila Healthcare Ltd. (now Zydus Lifesciences)
- Equipment flaws and cleaning deficiencies causing cross-contamination of drug products
- Shared equipment not adequately cleaned between product changeovers
- Warning Letter WL 320-20-05 issued Oct 2019; later resolved with compliance letter
Novel Laboratories Inc. (Lupin Somerset)
- CGMP violations at finished dosage manufacturing facility
- Inspection led to Warning Letter (613385, Apr 2023)
Dr. Reddy's Laboratories Ltd.
- CD Spectropolarimeter data for sameness study omitted from report submitted to FDA
- Original electronic data not attributable — spectra could not be traced to specific batches
- Equipment use logbook page 99 went missing; original notebook destroyed
- Data not recorded contemporaneously; sameness study report did not disclose discrepancies
Dr. Reddy's Laboratories Ltd. (Biologics)
- No adventitious virus testing on unprocessed bulks for non-US market products sharing equipment with US market manufacturing
- Cleaning validation procedures not effective — study did not include swab samples
- Shared equipment not adequately sampled and tested for residues after cleaning
Zydus Lifesciences Limited
- Cleaning Validation Master Plan incorrectly identified the hardest-to-clean/most toxic API
- Cleaning validation study failed to assess cleanability on the full range of product-contact surfaces
- Multiple batches of finished drug product on the affected line were cross-contaminated
Ipca Laboratories Ltd.
- Form 483 issued following inspection of finished dosage manufacturing facility
- Specific observations not publicly disclosed
Pre-Inspection Preparation
How to Prepare
- 1 Review your Cleaning Validation Master Plan and verify the worst-case API is correctly identified using current toxicity data (PDE/ADE/HBEL) — Akhtar found the wrong API identified at both Cadila and Zydus, leading to cross-contaminated finished product.
- 2 Ensure cleaning validation studies include swab sampling of all product-contact surfaces, not just rinse samples — at Dr. Reddy's Biologics, he cited the absence of swab samples as a critical gap.
- 3 Verify that shared equipment between products (or between US and non-US market manufacturing) has documented, validated cleaning procedures with residue acceptance criteria specific to each product transition.
- 4 Audit your complaint investigation backlog: ensure all complaints are investigated within your SOP timelines, trending is current, and investigations are extended to other potentially affected batches — the 3,000+ uninvestigated complaints at Cipla Pithampur became a warning letter.
- 5 Check that all original electronic laboratory data (chromatograms, spectra, instrument logs) is retained, attributable to specific batches, and matches any summary reports submitted to regulators — Akhtar traced missing CD spectropolarimeter data at Dr. Reddy's back to destroyed notebooks.
- 6 Ensure equipment use logbooks are complete with no missing pages — at Dr. Reddy's Bachupally, a missing logbook page and destroyed original notebook were cited as data integrity failures.
- 7 Review complaint investigation SOPs to verify they require root cause analysis (not just trend reporting) and mandate assessment of whether the finding extends to other products manufactured on the same equipment.
- 8 For biologics facilities: confirm adventitious virus testing is performed on all unprocessed bulk products manufactured on shared equipment, regardless of intended market — Akhtar cited this gap at Dr. Reddy's Biologics.
- 9 Conduct a pre-inspection self-assessment of cross-contamination controls: trace your cleaning validation data through to actual finished product testing results to verify no contamination is present — Akhtar follows this exact chain during inspections.
- 10 Ensure all data supporting sameness studies, method validation, or regulatory submissions is complete, contemporaneous, and includes all raw instrument data — not just processed summaries.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
Download Saleem A. Akhtar — FDA Investigator Profile
Enter your details once to unlock all Audit Hub resources. All future downloads are instant.
Leucine is the first AI-native platform built for pharmaceutical manufacturing. It unifies quality management, regulatory compliance, and production operations into one intelligent system that powers your entire drug manufacturing lifecycle from raw materials to patient delivery.
