FDA Inspection
Grato Holdings, Inc.Grato Holdings, Inc. – FDA Inspection, Mar 25, 2011
Record Details
This FDA Inspection record concerns Grato Holdings, Inc., with an inspection on March 25, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Grato Holdings, Inc.
- Inspection Date
- March 25, 2011
- Product Type
- Drugs
View Company Profile
ID · 9556ed66-8281-4ef2-b4ea-d54536cd0832
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 712890
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188(b)(2)Identity of major equipment and lines used
- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
- 21 CFR 211.198(a)Quality Control Review
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.130(e)Packaging line inspection documentation
- 21 CFR 211.100(a)Absence of Written Procedures
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 |
| July 14, 2021 | VAI | 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 1146470 - 2021-07-14
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