Hawknad Manufacturing Industries, Inc
Form 483 issued April 23, 2015 · Alexandria, Virginia
- Inspection
- Mar 30 – Apr 23, 2015
- Investigator
- James Michael Simpson
- Observations
- 12
- Pages
- 7
- FEI number
- 3005307300
In short: On April 23, 2015, FDA issued a Form 483 with 12 observations to Hawknad Manufacturing Industries, Inc in Alexandria, Virginia (FEI 3005307300) after an inspection that ran Mar 30 – Apr 23, 2015. The investigator was James Michael Simpson. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 211.22(d)21 CFR 211
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 03
Employees are not given training in current good manufacturing practices and written procedures required by current…
- 04
Where data from accelerated studies was used to project a tentative expiration date beyond a date…
This inspection in context
James Michael Simpson
7 documents · 2015–2018
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Virginia.
The firmHawknad Manufacturing Industries, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hawknad Manufacturing Industries, Inc?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Hawknad Manufacturing Industries, Inc?
James Michael Simpson is named on this Form 483, for the inspection of Mar 30 – Apr 23, 2015. Each investigator has a profile showing what they cite most.
When was Hawknad Manufacturing Industries, Inc inspected by FDA?
The inspection ran Mar 30 – Apr 23, 2015, and the Form 483 is dated April 23, 2015.
How do I get the full Form 483 for Hawknad Manufacturing Industries, 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.