FDA WARNING_LETTER - Grimm Scientific Industries - March 02, 2012

On February 27, 2012, an FDA inspection of Grimm Scientific Industries in Marietta, Ohio, revealed that the firm manufactures CRYOTherm, CRYOPress, and PARATherm devices. The CRYOTherm Model 4812 Heat Pump and Model 4802 Chiller were found to be adulterated and misbranded. These devices differ significantly from the previously cleared device (K864721) due to thermostatically-controlled heating/cooling and user interface changes, requiring a new 510(k) clearance per 21 CFR 807.81(a). The firm failed to notify the FDA of its intent to introduce the modified device into commercial distribution, violating section 510(k) of the Act.

The inspection also identified numerous Quality System (QS) regulation violations (21 CFR Part 820), indicating non-conformity with Current Good Manufacturing Practice (CGMP) requirements. Deficiencies included: 1. **Finished Device Acceptance (21 CFR 820.80(d)):** No written procedure, lack of signatures/dates on 12 CRYOTherm records, and 4 records not documenting passing test requirements. 2. **Nonconforming Product Control (21 CFR 820.90(a)):** Three CRYOTherm records showed out-of-specification psi