FDA Inspection
Grato Holdings, Inc.Grato Holdings, Inc. – FDA Inspection, Jul 14, 2021
Record Details
This FDA Inspection record concerns Grato Holdings, Inc., with an inspection on July 14, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Grato Holdings, Inc.
- Inspection Date
- July 14, 2021
- Product Type
- Drugs
View Company Profile
ID · a07a04e4-b9cb-4a72-a584-08f79c55b940
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1146470
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Grato Holdings, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 16, 2026 | Not classified | Kansas City District Office | |
| February 3, 2026 | Not classified | Kansas City District Office | |
| September 19, 2025 | VAI | Kansas City District Office | Drug Quality Assurance |
| July 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Grato Holdings, Inc.
- FDA Inspection 1316718 - 2026-04-16
- FDA Inspection 1301428 - 2026-02-03
- FDA Inspection 1282396 - 2025-09-19
- FDA Inspection 1175267 - 2022-07-14
- FDA Inspection 1111988 - 2019-12-06
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