FDA Inspection
Seachem Laboratories IncSeachem Laboratories Inc – FDA Inspection, Jan 31, 2012
Record Details
This FDA Inspection record concerns Seachem Laboratories Inc, with an inspection on January 31, 2012, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Seachem Laboratories Inc
- Inspection Date
- January 31, 2012
- Product Type
- Veterinary
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ID · 38e6ac6d-8bef-4166-95d2-eff38e5d825d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766544
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
16- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.194(a)(7)Signatures and dates--person who performs test
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Seachem Laboratories Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2024 | Not classified | Atlanta District Office | |
| October 19, 2021 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Seachem Laboratories Inc
- FDA Inspection 1251985 - 2024-10-17
- FDA Inspection 1155444 - 2021-10-19
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