Anastasia M. Shields
Consumer Safety Officer / Investigator
FDA India Office (New Delhi)
Detail-oriented investigator specialising in aseptic manufacturing, contamination control, and environmental monitoring — with a track record of high-impact inspections across India, the US, and Europe.
Inspection Approach
How Anastasia Inspects
Shields employs a methodical, systems-based inspection approach, starting with environmental monitoring programmes and working backwards through contamination control strategies, cleaning validation, and personnel practices. She is known for requesting raw environmental monitoring data sets (not just summaries), reviewing individual isolate identification records, and tracing media fill failures back to facility and HVAC qualification deficiencies.
A hallmark of her approach is direct observation of aseptic filling operations. She watches operators in real time, noting exact intervention times, personnel behaviour around sterile product, and whether settle plates and monitoring equipment are positioned where manipulations actually occur. She consistently checks whether surface monitoring includes product-contact surfaces like stopper bowls, stopper tracks, and intervention tools — a pattern confirmed across inspections in India (Fresenius Kabi, Kilitch Healthcare) and Europe (Pharmathen International in Greece).
She pays particular attention to whether risk assessments are genuine or retroactive justifications. Across multiple 483s, she has cited firms whose EM location risk assessments merely justified existing sampling points rather than genuinely evaluating where contamination risk is highest. She also consistently flags the absence of neutralising agents in EM media where spray disinfectants are used — a finding that appears in virtually every aseptic facility she inspects.
Citation Patterns
Top Focus Areas
Inspection History
Notable Inspections
Eugia Pharma Specialities Limited
- Environmental monitoring programme did not include adequate trending of isolate identification data
- Cleaning validation studies did not evaluate worst-case hold times for equipment contact surfaces
- Media fill failures were not investigated with sufficient depth to identify root cause
Zydus Lifesciences Limited
- Alert and action limits for environmental monitoring were not scientifically justified based on facility historical data
- Sporicidal agent effectiveness was not validated for all surface types in aseptic processing areas
Brassica Pharma Pvt Ltd
- Inadequate contamination control procedures for sterile manufacturing
- Environmental monitoring sample locations not risk-assessed
Kilitch Healthcare India Limited
- EM sampling locations not selected considering routine aseptic operations and interventions
- Surface monitoring did not include tools used for interventions, the stopper bowl, and the stopper track
- In-house prepared EM media did not contain neutralisers — spray disinfectant was sprayed directly over settle plates during setup
- Contact plates prepared in-house did not have sufficient media above the rim; 27 plates showed issues, 8 showed desiccation
Fresenius Kabi Oncology Limited
- Risk assessments for EM sampling locations merely justified existing points rather than genuinely assessing risk
- Settle plates in RABS not positioned near where interventions routinely occur
- Surface monitoring did not include stopper bowl or stopper track contacting sterile stoppers
- Air monitoring media contained no neutralising agents despite spray disinfectants being used in filling rooms
- Operators repeatedly leaned over sterile product and reached over open vials with non-sterile portions of RABS
Pharmathen International S.A.
- Settle plates in Grade A area not positioned in accordance with procedure during aseptic filling
- EM programme did not include sampling of product-contact surfaces: stopper bowl, stopper track, forceps
- Non-viable monitoring stopped while sterile product-contact equipment was still exposed
- EM plates did not include neutralisers despite spray disinfectants being routinely used in Grade A and B areas
Pre-Inspection Preparation
How to Prepare
- 1 Ensure environmental monitoring trending reports include individual isolate identification data — not just pass/fail summaries. Shields is known to request raw data sets.
- 2 Validate that your alert and action limits are justified by your facility's historical data, not adopted from industry guidelines without site-specific assessment.
- 3 Review cleaning validation studies for worst-case scenarios: maximum hold times, most difficult-to-clean equipment, and residue carryover calculations.
- 4 Confirm sporicidal agent effectiveness is validated for every surface type and material in your aseptic processing areas — not just stainless steel.
- 5 Prepare a comprehensive contamination control strategy document that integrates environmental monitoring, cleaning validation, personnel monitoring, and facility qualification data.
- 6 Verify media fill investigation records are thorough — Shields expects root cause identification beyond "operator error" with objective evidence of corrective action.
- 7 Ensure personnel gowning qualification records show defined re-qualification frequency with documented rationale.
- 8 Have HVAC qualification data readily accessible, including airflow visualisation studies and pressure differential trending for classified areas.
- 9 Ensure non-viable particle monitoring is conducted during actual aseptic operations and that monitoring equipment is positioned facing toward the area where manipulations occur — not away from it.
- 10 Verify all EM media (settle plates, active air, contact plates) contain appropriate neutralising agents if spray disinfectants are used anywhere in the classified area — this is cited in virtually every Shields 483.
Commonly Cited Regulations
Top CFR Citations
Frequently Paired With
Co-Investigators
Geographic Reach
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