FDA Inspection
Greer Laboratories, Inc.Greer Laboratories, Inc. – FDA Inspection, Sep 11, 2019
Record Details
This FDA Inspection record concerns Greer Laboratories, Inc., with an inspection on September 11, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d983e126-dca4-4443-aca5-fdcac7ee242a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102216
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(d)Rejected in-process materials not quarantined
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 111.120(c)Quality control operations - material review, disposition decision
- 21 CFR 123.8(a)(3)(ii)Corrective action record review adequacy
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Other FDA inspections of Greer Laboratories, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2025 | Not classified | Atlanta District Office | |
| December 18, 2024 | VAI | Atlanta District Office | Vaccine, Allergenic, and Live Biotherapeutic Products |
| November 1, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 22, 2017 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 15, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Greer Laboratories, Inc.
- FDA Inspection 1294986 - 2025-12-12
- FDA Inspection 1256993 - 2024-12-18
- FDA Inspection 1182373 - 2022-11-01
- FDA Inspection 1036168 - 2017-11-22
- FDA Inspection 1014272 - 2017-06-15
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