FDA Inspection
Westlab Pharmacy, Inc. dba Westlab PharmacyWestlab Pharmacy, Inc. dba Westlab Pharmacy – FDA Inspection, Aug 15, 2018
Record Details
This FDA Inspection record concerns Westlab Pharmacy, Inc. dba Westlab Pharmacy, with an inspection on August 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1e513fa1-4422-41c1-9838-07f9715738e0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1062163
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
9- FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
- 21 CFR 211.137(a)Expiration date lacking
- FDCA 501(a)(2)(A)Exposure of personnel in aspectic processing
- 21 CFR 211.165(a)Testing and release for distribution
- FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
- FDCA 501(a)(2)(A)Location, ISO 5 classified area
- 21 CFR 211.80(a)Procedures To Be in Writing
- FDCA 501(a)(2)(A)Actionable microbial contamination, ISO 5 area
- FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components
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Other FDA inspections of Westlab Pharmacy, Inc. dba Westlab Pharmacy
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Westlab Pharmacy, Inc. dba Westlab Pharmacy
- FDA Inspection 1155844 - 2021-10-05
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