FDA Inspection
Greer Laboratories, Inc.Greer Laboratories, Inc. – FDA Inspection, Dec 18, 2024
Record Details
This FDA Inspection record concerns Greer Laboratories, Inc., with an inspection on December 18, 2024, issued by the Atlanta District Office, covering biologics.
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ID · 2830b235-dbe8-4655-96d9-10c09b781104
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1256993
- FDA center
- Biologics
- Project area
- Vaccine, Allergenic, and Live Biotherapeutic Products
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(b)Written procedures not established/followed
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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 | |
| November 1, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 11, 2019 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| 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 1182373 - 2022-11-01
- FDA Inspection 1102216 - 2019-09-11
- FDA Inspection 1036168 - 2017-11-22
- FDA Inspection 1014272 - 2017-06-15
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