FDA Inspection
Dercher Enterprises, Inc., DBA Gordon LaboratoriesDercher Enterprises, Inc., DBA Gordon Laboratories – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Dercher Enterprises, Inc., DBA Gordon Laboratories, with an inspection on March 29, 2019, issued by the Philadelphia District Office, covering human drugs.
- Inspection Date
- March 29, 2019
- Product Type
- Human Drugs
View Company Profile
ID · 840497ef-8bf1-4f67-9082-916d5118fa62
Inspection Facts
- Inspection number
- 1085952
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Dercher Enterprises, Inc., DBA Gordon Laboratories
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 13, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 19, 2017 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| January 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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