FDA Inspection
Massco DentalMassco Dental – FDA Inspection, Oct 29, 2010
Record Details
This FDA Inspection record concerns Massco Dental, with an inspection on October 29, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Massco Dental
- Inspection Date
- October 29, 2010
- Product Type
- Drugs
View Company Profile
ID · 8209f4d0-01ce-4d0c-a29e-59b214e52648
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695768
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.184(d)Labeling: documentation of exam and review
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(1)Sample size - test intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Massco Dental
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 8, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Massco Dental
- FDA Inspection 1178803 - 2022-09-02
- FDA Inspection 990480 - 2016-08-18
- FDA Inspection 887950 - 2014-07-18
- FDA Inspection 574456 - 2009-04-08
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