Sklar BOV Solutions, Inc.
Form 483 issued March 7, 2018 · Statesville, North Carolina
- Inspection
- Feb 27 – Mar 7, 2018
- Investigators
- Adam R. Cooke· Seneca Toms
- Observations
- 8
- Pages
- 5
- FEI number
- 3007953761
In short: On March 7, 2018, FDA issued a Form 483 with 8 observations to Sklar BOV Solutions, Inc. in Statesville, North Carolina (FEI 3007953761) after an inspection that ran Feb 27 – Mar 7, 2018. The investigators were Adam R. Cooke and Seneca Toms. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmSklar BOV Solutions, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sklar BOV Solutions, Inc.?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sklar BOV Solutions, Inc.?
Adam R. Cooke and Seneca Toms are named on this Form 483, for the inspection of Feb 27 – Mar 7, 2018. Each investigator has a profile showing what they cite most.
When was Sklar BOV Solutions, Inc. inspected by FDA?
The inspection ran Feb 27 – Mar 7, 2018, and the Form 483 is dated March 7, 2018.
How do I get the full Form 483 for Sklar BOV Solutions, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.