# FDA WARNING_LETTER - Eastern Cranial Affiliates, LLC - June 18, 2010

Source: https://www.keypedia.com/records/warning_letter/eastern-cranial-affiliates-llc/575081e1-e2ab-4767-889b-f31dc86f0eab

> FDA WARNING_LETTER for Eastern Cranial Affiliates, LLC on June 18, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Eastern Cranial Affiliates, LLC
- Inspection Date: 2010-06-18
- Product Type: Devices
- Office Name: Baltimore District Office
- Summary: On November 16, 2010, the FDA issued a Warning Letter to Eastern Cranial Affiliates, LLC, following a June 2010 inspection. The inspection revealed that the firm's KidCap Cranial Molding Orthosis devices are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Violations include:
1.  Failure to establish and maintain procedures for changes to procedures (21 C.F.R. § 820.70(b)), specifically regarding an unverified/unvalidated manufacturing change for the KidCap.
2.  Failure to validate processes where results cannot be fully verified by inspection and test (21 C.F.R. § 820.75(a)), including unvalidated production changes for patient head measurement using a digital scanner and unvalidated mold production changes.
3.  Failure to establish a quality plan relevant to device design and manufacture (21 C.F.R. § 820.20(d)).
4.  Failure to conduct reviews of manufacturing procedures and appoint a management representative for quality system requirements (21 C.F.R. § 820.20(c

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- [District Director](https://www.keypedia.com/people/evelyn-bonnin/3fdb9ef8-ea23-4a86-9176-cab37e5dea36)

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