FDA Inspection
Progenics Pharmaceuticals, Inc.Progenics Pharmaceuticals, Inc. – FDA Inspection, Mar 20, 2020
Record Details
This FDA Inspection record concerns Progenics Pharmaceuticals, Inc., with an inspection on March 20, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 20, 2020
- Product Type
- Drugs
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ID · 50e04dbd-417c-4069-afcc-c970d5d2bd17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1121240
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Progenics Pharmaceuticals, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Progenics Pharmaceuticals, Inc.
- FDA Inspection 1206225 - 2023-04-21
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