Blendpack, Inc.
Form 483 issued November 1, 2024 · Cleveland, Tennessee
- Observations
- 4
- Pages
- 4
- FEI number
- 3013095463
In short: On November 1, 2024, FDA issued a Form 483 with 4 observations to Blendpack, Inc. in Cleveland, Tennessee (FEI 3013095463). Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 210
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 03
Specific identification tests are not conducted on components that have been accepted based on the…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Questions about this 483
What did FDA find at Blendpack, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
When was Blendpack, Inc. inspected by FDA?
This Form 483 is dated November 1, 2024.
How do I get the full Form 483 for Blendpack, 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.